TY - JOUR
T1 - Complications associated with transobturator sling procedures
AU - Boyles, Sarah Hamilton
AU - Edwards, Renee
AU - Gregory, William
AU - Clark, Amanda
N1 - Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2007/1
Y1 - 2007/1
N2 - This study aims to determine the complications associated with trans-obturator slings as reported to a national database. We required "MAUDE", a database that collects reports of complications associated with medical devices and which is maintained by the Food and Drug Administration. We searched for complications associated with three different, commercially available trans-obturator slings. We then tabulated the results by type of complication, by date of occurrence, and by type of sling. Between January 2004 and July 2005, 140 reports of 173 complications associated with trans-obturator tapes were reported to the MAUDE database. Previously unreported injuries, such as obturator nerve injuries, large blood losses (≥600cc), and ischiorectal fossa abscesses, were documented. Serious complications occur with the trans-obturator tape systems, but the rates are unknown due to database limitations. The type of complication appears to differ between devices and this may reflect different implantation systems and different polypropylene mesh formulations. Improved tracking of device complications is necessary to maximize patient safety.
AB - This study aims to determine the complications associated with trans-obturator slings as reported to a national database. We required "MAUDE", a database that collects reports of complications associated with medical devices and which is maintained by the Food and Drug Administration. We searched for complications associated with three different, commercially available trans-obturator slings. We then tabulated the results by type of complication, by date of occurrence, and by type of sling. Between January 2004 and July 2005, 140 reports of 173 complications associated with trans-obturator tapes were reported to the MAUDE database. Previously unreported injuries, such as obturator nerve injuries, large blood losses (≥600cc), and ischiorectal fossa abscesses, were documented. Serious complications occur with the trans-obturator tape systems, but the rates are unknown due to database limitations. The type of complication appears to differ between devices and this may reflect different implantation systems and different polypropylene mesh formulations. Improved tracking of device complications is necessary to maximize patient safety.
KW - Complications
KW - MAUDE database
KW - Stress
KW - Trans-obturator sling
KW - Urinary incontinence
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U2 - 10.1007/s00192-006-0091-0
DO - 10.1007/s00192-006-0091-0
M3 - Article
C2 - 16568214
AN - SCOPUS:34248373664
SN - 0937-3462
VL - 18
SP - 19
EP - 22
JO - International Urogynecology Journal
JF - International Urogynecology Journal
IS - 1
ER -